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Failed clinical trials come at a huge cost to their pharmaceutical sponsors. Many trial sites fail to enroll more than a single patient—up to 60% of oncology trials, according to Covance, for example. Yet they estimate it costs a sponsor $50,000 for a site start-up, with a loss of almost $2 billion between 2006-2010 from non-performing sites.

I raise this issue as part of a New Year’s resolution to try to boost clinical trial participation. In part reminded of the importance of volunteering by Nina Martinez’s (@marganina) posts on her participation in HIV trials, and Lisa Bonchek Adams’ (@adamslisa) important posts detailing her experience on trials for metastatic breast cancer, I recently enrolled on an NIH clinical trial for hyperlipidemia.

I’ve volunteered for several trials over the years, beginning in college. That’s part of what boosted my interest in medicine and conducting clinical research. As an investigator, my threshold for accepting a clinical trial was whether or not I would be willing to be a participant or have a family member participate. In fact, my husband and I were both volunteers on my very first trial, Trospectomycin in the treatment of pneumonia, enrolled by a co-investigator. Unfortunately, this is no longer allowed—it was quite reassuring to patients, however.

My first visit at NIH went very smoothly, once we got through the insane security procedures. The clinical coordinator reviewed the consent form with me, then I met this friendly phlebotomist who put me right at ease. The coordinator escorted me from one study procedure to the next. Finally, at the end, I had an opportunity to ask more questions.

What are the barriers to clinical trials?

The biggest barrier in recruitment is lack of encouragement or support from the attending physician. Many physicians simply are unaware of clinical trials that might benefit their patient. Further, with the increasing pressure to see patients more and more quickly, they simply don’t have the time to engage in lengthy discussions with patients. Many are also concerned about lack of control—it is critical that the trial physician communicate regularly with the primary physician.

Insurance or HMO policies that may preclude reimbursement for care. This is less of an issue with cancer trials than previously.

HIPAA is one thing that killed my ability to conduct trials, particularly as the infectious diseases protocols had a very narrow window for enrollment. One easy way for centers to avoid this is to have a simple statement when patients are registering for care asking, “Would you like to be informed of possible clinical trials you might participate in?” IRBs can also issue waivers for screening, since even they understand you have to know of a patient’s existence before you can approach them.

Standardized order sets for “quality” were also a major problem. Pneumonia sets typically included “Levaquin or Ceftriaxone-Azithromycin” as options. Call Dr. Stone for pneumonia study was not an option, and doctors were afraid of being chastised. Also, once a prospective patient has received an antibiotic, they become ineligible for the trial.

Lower income⁠ is also predictive of lower participation in clinical trials, surprisingly even among Medicare patients. At the same time, I had to be exceedingly careful with patients in trials whose main interest was that it would provide the only access to health care they could get.

Women have also been notoriously underrepresented in clinical trials. For example, of 258 cardiovascular clinical trials⁠ studied, women made up only 27% of the population. In another 196 trials which included both genders, only 33% reported gender-based outcomes, despite NIH mandates to do so. I brought up the disparities in how men and women with chest pain or cardiovascular disease were treated when I was a med student; my questions were met with disdain. Since then, it's been found that women with acute cardiovascular disease present quite differently from men with the same disease.

Most importantly, there needs to be more education of physicians and by them. Their administrative burden needs to be reduced, perhaps by having coordinators do more of the screening and patient education. Some sites have found brief videos to be effective for providing an overview on clinical trials, via a tool called PRE-ACT ⁠(Preparatory Education About Clinical Trials). The videos are tailored to the patient based on their responses to a survey. Imagine if the TV in doctors’ offices ran educational material, instead of Fox news!